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About CSI

We are devoted to developing innovative solutions for treating peripheral and coronary artery disease, to help physicians conquer calcium, one of the largest challenges when treating PAD and CAD and help patients get back to what matters.

Read about our company policies, monitoring, public disclosures and other details.

Hospital Administration

INDICATIONS & IMPORTANT SAFETY INFORMATION

DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS)
Indication: To facilitate stent delivery in patients with coronary artery disease who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.Contraindications: The OAS is contraindicated when the VIPERWIRE guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions; A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.
See the Instructions for Use before performing DIAMONDBACK 360® coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.DIAMONDBACK 360® Peripheral Orbital Atherectomy SystemIndications: For use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.Contraindications: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present.Adverse Events: Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Improve patient outcomes and reduce healthcare costs

As a hospital administrator, you often face difficult and demanding challenges every day. You need to prepare for the demands of an aging population. You must improve patient care by recruiting the most talented staff and you must acquire the most efficient, effective technology.

Plus, you have to navigate the uncertainty of healthcare reform, including Medicare and Medicaid reimbursements and the transition from fee-for-service to alternative payment models (APMs). All while streamlining costs and maintaining fiscal responsibility. At CSI, we are committed to offering technology that helps improve patient outcomes and delivers value.

Treat Peripheral Artery Disease

Orbital atherectomy can be a critical element in a revascularization-first strategy. Amputation is among the costliest treatment options.36,37 The cost for an advanced PAD patient, one with critical limb ischemia (CLI), following a lower extremity amputation is $49,000 annually.12

Revascularization procedures result in demonstrated improvements in patient outcomes and reduced costs when compared to amputation.13,14,37 It’s estimated that a 25% reduction of amputations could save $2.9 billion to $3 billion in healthcare expenditures in the US13,14

$212billion

to

*Includes inpatient and outpatient costs, including all-cause hospitalizations, medications and other costs for PAD patients in the US REACH population in 2015 ($10,881 x 19.5 million people with PAD) and managed care population in 2014 ($19,963 x 19.5 million people with PAD). Range calculated by The SAGE Group, 2015.

Treat Severely Calcified Coronary Lesions

The annual burden of illness due to coronary artery calcification is estimated at between $1 billion and $3 billion.18 The burden for all heart diseases will escalate in the future, according to the American Heart Association (AHA). The AHA estimates that by 2030, 40.5% of the US population will have some form of cardiovascular disease, costing an estimated US $818 billion.4

Example only based on United States national estimates. Actual reimbursement rates may vary. Estimated Medicare national average overhead. ORBIT II cost-effectiveness study7 with Extrapolation of 1-year economic data to 2-year estimates by Brad J. Martinsen, Ph.D. (CSI). Regression analysis with a Power line fit to give predicted 730-day cost offset/savings. Podium Presentation at EuroPCR 2015, Paris and Data on file at CSI. Medicare comparison sample was drawn from the 100% Standard Analytical File for reported period. The base case analysis was restricted to calcification patients from hospitals (N=17) reporting more the 10% of stent patients with calcification during this initial period. PCI patients with severely calcified lesions with acute coronary syndrome. Study design and enrollment criteria differ from ORBIT II.

Commitment to Clinical & Economic Rigor

Physicians and payers are increasingly seeking clinical and economic evidence to allow them to make decisions regarding optimal treatment of patients. We are focused on conducting and collecting clinical and economic evidence to demonstrate the advantages of OAS in treating complex disease states such as PAD and CAD.

We believe that the clinical data and cost-effectiveness of our OAS technology will help drive physician utilization of the OAS and sustain ongoing reimbursement coverage for our devices.11

In July 2018, Cardiovascular Systems, Inc. (CSI®) announced that OrbusNeich Medical Co. Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral Orbital Atherectomy Systems outside the United States and Japan.

In November 2016, Cardiovascular Systems, Inc. (CSI®) announced that Medikit, Co., Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral Orbital Atherectomy Systems in Japan.

Smart Solutions that advance treatment for complex patients

At CSI, weare a culture of innovation.
We observe carefully, listen closely and collaborate extensively,
seeking opportunities to help interventionalists do their jobs more easily and more effectively –
all with the goal of improving patient care.